The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook-swartz Doppler Flow Probe.
| Device ID | K171272 |
| 510k Number | K171272 |
| Device Name: | Cook-Swartz Doppler Flow Probe |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Tom Kardos |
| Correspondent | Tom Kardos Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-01 |
| Decision Date | 2018-07-17 |
| Summary: | summary |